Ramipril and Cardiovascular Outcomes in Patients on Maintenance Hemodialysis: The ARCADIA Multicenter Randomized Controlled Trial
| Autor: | Federico Pieruzzi, Jorge Hidalgo Godoy, Antonello Pani, Claudio Pozzi, Andrea Galfré, Silvio Bertoli, Hans-Joachim Anders, Giovanni Mosconi, Giuseppe Daidone, Simonetta Genovesi, E. Mambelli, Giulio Mingardi, Goffredo Del Rosso, Agnese Meterange-Lis, Annalisa Perna, Piero Ruggenenti, Antonio Granata, Angelo Rigotti, Matias Trillini, Manuel Alfredo Podestà, Salvatore David, Carmela Giuseppina Condemi, Tobia Peracchi, Sonia Pasquali, Patrizia Ondei, Davide Villa, Giorgio Romei Longhena, Carlo Guastoni, Maurizio Garozzo, Nadia Rubis, Monica Cortinovis, Davide Martinetti, Giuseppe Remuzzi, Alfonso Pacitti |
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| Přispěvatelé: | Ruggenenti, P, Podesta, M, Trillini, M, Perna, A, Peracchi, T, Rubis, N, Villa, D, Martinetti, D, Cortinovis, M, Ondei, P, Condemi, C, Guastoni, C, Meterangelis, A, Granata, A, Mambelli, E, Pasquali, S, Genovesi, S, Pieruzzi, F, Bertoli, S, Del Rosso, G, Garozzo, M, Rigotti, A, Pozzi, C, David, S, Daidone, G, Mingardi, G, Mosconi, G, Galfre, A, Romei Longhena, G, Pacitti, A, Pani, A, Hidalgo Godoy, J, Anders, H, Remuzzi, G |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Ramipril
Male medicine.medical_specialty Epidemiology medicine.medical_treatment Angiotensin-Converting Enzyme Inhibitors Critical Care and Intensive Care Medicine law.invention Randomized controlled trial law Renal Dialysis Multicenter trial Internal medicine ACE inhibitor medicine Clinical endpoint media_common.cataloged_instance Humans Prospective Studies European union Stroke media_common Aged Transplantation renin angiotensin system business.industry Editorials Middle Aged medicine.disease cardiovascular event Clinical trial hemodialysi Nephrology Cardiovascular Diseases Female Hemodialysis business medicine.drug |
| Zdroj: | Clin J Am Soc Nephrol |
| Popis: | Background and objectives Renin-angiotensin system (RAS) inhibitors reduce cardiovascular morbidity and mortality in patients with CKD. We evaluated the cardioprotective effects of the angiotensin-converting enzyme inhibitor ramipril in patients on maintenance hemodialysis. Design, setting, participants, & measurements In this phase 3, prospective, randomized, open-label, blinded end point, parallel, multicenter trial, we recruited patients on maintenance hemodialysis with hypertension and/or left ventricular hypertrophy from 28 Italian centers. Between July 2009 and February 2014, 140 participants were randomized to ramipril (1.25–10 mg/d) and 129 participants were allocated to non-RAS inhibition therapy, both titrated up to the maximally tolerated dose to achieve predefined target BP values. The primary efficacy end point was a composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included the single components of the primary end point, new-onset or recurrence of atrial fibrillation, hospitalizations for symptomatic fluid overload, thrombosis or stenosis of the arteriovenous fistula, and changes in cardiac mass index. All outcomes were evaluated up to 42 months after randomization. Results At comparable BP control, 23 participants on ramipril (16%) and 24 on non-RAS inhibitor therapy (19%) reached the primary composite end point (hazard ratio, 0.93; 95% confidence interval, 0.52 to 1.64; P=0.80). Ramipril reduced cardiac mass index at 1 year of follow-up (between-group difference in change from baseline: −16.3 g/m2; 95% confidence interval, −29.4 to −3.1), but did not significantly affect the other secondary outcomes. Hypotensive episodes were more frequent in participants allocated to ramipril than controls (41% versus 12%). Twenty participants on ramipril and nine controls developed cancer, including six gastrointestinal malignancies on ramipril (four were fatal), compared with none in controls. Conclusions Ramipril did not reduce the risk of major cardiovascular events in patients on maintenance hemodialysis. Clinical Trial registry name and registration number: ARCADIA, NCT00985322 and European Union Drug Regulating Authorities Clinical Trials Database number 2008–003529–17. |
| Databáze: | OpenAIRE |
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